Services in the field of drug products
Our services include:
Regulatory Affairs
- New submission of marketing authorization application (any type of applications)
- Maintenance of marketing authorization (renewal, variations)
- Preparation of Modules 1-5 of the registration dossier
- Preparation of the Swiss Module 1
- Preparation of Swiss product information and labelling
- Creation of eCTD sequences and electronic dossiers in eDok format
- Submission of PSUR / PBRER
- Preparation of GSASA questionnaire for hospital products
- Evaluation and GAP analysis of registration files
Reimbursement
- Preparation of new application for admission to the list of specialties (SL) for original preparations and for generics
- Application for new pack size and dosage
- Application for a new clinical indication·
- Triennial reevaluation of the admission to the SL
Quality Management
- Application for an establishment license (import, export, wholesale, trade in foreign countries)
- Preparation of a Site Master File
- Preparation of inspections performed by authorities
- Establishment and maintenance of a quality management system (QMS) which fulfills the GMP/GDP guidelines
- Development, review and updating of Standard Operating Procedures (SOPs) and GxP agreements
- Preparation and execution of audits (internal audits, audits of suppliers and service providers)
- Qualification of suppliers or service providers
- Management of transport issues
- Management of changes
- Management of deviations
- Batch release for the Swiss market
- Preparation and execution of management reviews
- Assessment of product quality reviews (PQR) and Swiss reviews
- Management of complaints, notification of product quality defects to Swissmedic
- Management of recalls
- Compliance to Falsified Medicines Directive
- Training in quality management system
Compliance
- Control of the promotional material considering the legal framework
- Evaluation of the feasibility of events for healthcare professionals
Pharmacovigilance
- Set-up and maintenance of pharmacovigilance SOPs which fulfill the ICH guidelines
- Preparation and support for authority inspections
- Management of Individual Case Safety reports (ICSRs)
- Management of signals
- Preparation of periodic safety update reports (PSUR/PBRER)
- Preparation and updates of risk management plans (RMPs)
- Periodic Swiss literature search
- Reconciliation
- PV audits
- Training